Pleura; Exudate, Pleural Effusion, Pleural Effusion, Malignant
Conditions
Keywords
Pleural effusion, Malignant Pleural effusion, Pleura diagnostics, US-guided pleural biopsy, Local anesthetic thoracoscopy
Brief summary
Pleural fluid can be caused by cancer. Patients with repeated presentation of pleural fluid where initial diagnostic tests have been inconclusive are the focus of this trial. In this clinical trial patients are randomized into two groups and the efficacy of local anesthetic thoracoscopy (LAT) is compared to an ultrasound guided biopsy of the outer lining of the lung. The aim is not only the diagnostic yield in diagnosing cancer, but also the procedures ability to diagnose specific cancer mutations and immune system markings. Methods and objectives: Patients with reoccuring one-sided pleural fluid, with a marked clinical risk of cancer based on findings in medical work-up, radiological scans, biochemistry and medical history and who are undiagnosed upon initial pleural fluid analysis are the target patients of the trial. Patients are randomized into two groups to have undertaken either pleural biopsy at the optimal site for a repeat thoracentesis or LAT. Thus diagnostic yield for both fluid analysis and biopsy analysis will be compared to tissue samples taken with LAT. We hypothesize that LAT is superior both to pleural biopsy and repeat thoracentesis in providing diagnostic clarification and providing sufficient basis for treatment without further procedures resulting in less time consumption, cost and discomfort for the patient.
Interventions
PROCEDURELocal anesthetic thoracoscopy
Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
PROCEDUREUS-guided pleural biopsy
In local anesthesia, a closed needle biopsy is performed Ultrasound guided of the parietal pleura at the place of deepest fluid recess in the intrathoracic space. A pigtail catheter French 7-16 is placed afterwards for fluid drainage.
Sponsors
Naestved Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older patients with single previous thoracentesis of a unilateral pleural exudate according to Lights criteria without malignant cells. * Lights Criteria: Pleural fluid protein/serum protein ratio greater than 0.5 pleural fluid LDH/serum LDH ratio greater than 0.6 Pleural fluid LDH greater than two-thirds the upper limits of the Laboratorys normal Serum LDH * Contrast enhanced CT of the Chest and abdomen performed * Clinical suspicion of cancer such as, but not limited to, weight loss, malaise, anemia * Pet-CT results or former cancer diagnosis Informed consent
Exclusion criteria
* bilateral pleural effusions * known cause of pleural effusion * likely non-malignant course of a unilateral pleura effusion such as (but not restricted to) pneumonia, trauma, pleuritis, heart failure * any contraindication to the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate, local anesthetic thoracoscopy vs 2. thoracentesis | 26 weeks | Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus 2nd thoracentesis |
| Incidence of treatment-guiding pleural workup to provide and plan treatment for the cause of the pleura exudate. Local anesthetic thoracoscopy vs US-guided pleural biopsy. | 26 weeks | Difference in incidence of treatment-guiding diagnostic workup in local anesthetic thoracoscopy versus US-guided pleural biopsy prior to 2nd thoracentesis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time from randomization to conclusive, treatment-guiding diagnoses | 26 weeks | — |
| Time from start of consultation with medical staff until end of consultation with medical staff on the day of the procedure | Day of procedure/intervention | — |
| Time from procedure start to patient leaving the procedure room and leaving the recovery room | Day of procedure/intervention | — |
| Adverse event; complication to procedure: mortality | 30 days. | Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system |
| Adverse event; complication to procedure: pneumothorax | 30 days. | Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system |
| Adverse event; complication to procedure: haemoptysis | 30 days. | Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system |
| Incidence of achieving pleural immunohistochemistry, mutations, oncodrivers, culture and biochemistry. | 26 weeks | — |
| Adverse event; complication to procedure: hospital admission | 30 days. | Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system |
| Total volume of pleural fluid removed | Day of procedure | In mililiter (ml) |
| Patient reported discomfort reported via ESAS | Day of procedure pre- and post-procedure and 1 week followup | ESAS - Edmonton Symptom Assesment System, Danish Version 2008 |
| Patient reported discomfort reported via EQ-5D-5L | Day of procedure pre- and post-proceudre and 1 week followup | Denmark (Danish) © 2009 EuroQol Group EQ-5D™ |
| Willingness to repeat procedure | After procedure performed - within 30 minutes and 1 week after proceudre | 5 Point Likert Scale, 1 not likely to repeat, 5 most likely to repeat |
| Cough | Pre-procedure, 1 week post procedure. | Visual analogue scale 1-10. 1 Being no cough, 10 being extreme cough |
| Adverse event; complication to procedure: infection | 30 days. | Evaluated on day of procedure, 7 days and 30 days. The 2 last are performed via telephone call to the patient and informations gathering in the electronic patient file system |
| Incidence of completed procedures | 1 week | — |
Countries
Denmark
Outcome results
None listed